Clearance Summary
ESTECH EASYFLOW CANNULA WITH GUIDEWIRE received FDA 510(k) clearance under submission number K091542, sponsored by Endoscopic Technologies, Inc. D/B/A Estech. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-10-20.
- Submission: K091542
- Applicant / Sponsor: Endoscopic Technologies, Inc. D/B/A Estech
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 2009-10-20
Classification & Regulation
This clearance is catalogued under FDA product code DWF and 21 CFR 870.4210, within the Cardiovascular review panel as a Class II device.